{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled \"Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause.\" The draft guidance document describes considerations for generating substantial evidence of effectiveness and evidence of safety of individualized therapies based on a plausible mechanism framework.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2026/02/25/2026-03713.html","cfr_references":[],"citation":"91 FR 9283","comment_url":null,"comments_close_on":"2026-04-27","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by April 27, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-D-1256"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-02-25","updated_at":"2026-02-25T10:00:08.545-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-D-1256-0001","allow_late_comments":false,"id":"FDA-2026-D-1256-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-D-1256","title":"Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause; Draft Guidance for Industry; Availability"}],"document_number":"2026-03713","effective_on":null,"end_page":9285,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/02/25/2026-03713.xml","html_url":"https://www.federalregister.gov/documents/2026/02/25/2026-03713/considerations-for-the-use-of-the-plausible-mechanism-framework-to-develop-individualized-therapies","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-03713?publication_date=2026-02-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-02-25/2026-03713/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1473,"last_updated":"2026-10-10 12:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-25/pdf/2026-03713.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-03713.pdf?1771863307","publication_date":"2026-02-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/02/25/2026-03713.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2026-D-1256","supporting_documents_count":0,"docket_id":"FDA-2026-D-1256","document_id":"FDA-2026-D-1256-0001","regulation_id_number":null,"title":"Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2026-02-25T15:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":9283,"subtype":null,"title":"Considerations for the Use of the Plausible Mechanism Framework To Develop Individualized Therapies That Target Specific Genetic Conditions With Known Biological Cause; Draft Guidance for Industry; Availability","toc_doc":"Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}